Clinical Operation Manager
il y a 7 jours
**Job summary**:
As an experienced **Clinical Operations Manager **you will be expected to develop and grow the team in France and support clients relationships for the assigned region. Reporting to the Executive Director Clinical Operations, you will be a key member of the **Clinical Operations team.**
We are searching for an experienced, ambitious and energetic person. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
**Main Tasks of the Position**:
- Responsible for setting up a physical office in the region of Lyon and willingness to work from this office 2 days per week and if needed
- Manages the day-to-day activities necessary for the successful completion of a project within EastHORN and client timelines and budget
- Responsible for establishing excellent working relationships with client project teams to ensure client satisfaction and operational excellence
- Supports business development activities in assigned region/ might participate in Business Development meeting calls or meetings with a Client and coordinates feasibility process
- Defines and manages project resource needs to ensure on-time and on-budget deliverables for assigned projects: completes allocation and demand table, reviews and approves timesheets
- Serves as the Project Lead for key business development opportunities, including the preparation and delivery of client presentations
- Provides Line Management to assigned staff
- Provides ongoing leadership and performance feedback to project team members
- Supports preparation of the study budget and site contract negotiations
- Identifies, contacts and manages external vendors if required for a successful study conduct
- Acts as an expert in regulatory affairs and operations in related CEE countries; supports regulatory submission and site contract negotiation processes
- Responsible for detailed performance review, identification of training needs and performance issues, and resolution of all issues for assigned Clinical Operations staff
- Conducts Quality Control and Co-monitoring visits with Clinical Research Associates to identify and ensure good performance and quality
- Responsible for clinical resource management and work allocation
- Assists in the clinical staff recruitment process
- May have administrative Head of Office role for EastHORN's assigned countries that includes overseeing legal aspects of EastHORN local office including, but not limited to: legal address, rent of the office, office admin supervision, admin supplies supervision, etc.; be responsible for finance aspects: country budget, salaries and bonuses, expenses approval etc.
**Required Qualifications, Experience, Competencies**
- 10+ years’ experience in clinical research
- 5+ years’ experience as manager in a CRO
- experiences with regulatory submissions and monitoring in other francophone countries (Switzerland, Belgium) is an asset
- Excellent knowledge of ICH-GCP guidelines
- Be aware of drug development process, in particular monitoring and site management skills
- Excellent skills to lead a clinical project team and to encourage team members to seek solutions
- Demonstrated skills to coach and mentor other clinical staff
- Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Excellent planning, time management and organizational skills to handle multiple priorities
- Ability to work independently and within a team environment
- Strong analytical capabilities and a very detail-oriented mindset
- Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets
- Excellent written and oral communication skills in English and French
**Benefits**:
- Working with experienced and very professional and supportive team
- Possibility to grow and develop within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme
- Benefits according to the country package
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